JP2950995B2 - Thin wall catheter with enhanced torque characteristics - Google Patents

Thin wall catheter with enhanced torque characteristics

Info

Publication number
JP2950995B2
JP2950995B2 JP7529480A JP52948095A JP2950995B2 JP 2950995 B2 JP2950995 B2 JP 2950995B2 JP 7529480 A JP7529480 A JP 7529480A JP 52948095 A JP52948095 A JP 52948095A JP 2950995 B2 JP2950995 B2 JP 2950995B2
Authority
JP
Japan
Prior art keywords
intravascular catheter
tubular body
outer layer
blend
peba
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
JP7529480A
Other languages
Japanese (ja)
Other versions
JPH09506026A (en
Inventor
ジュ，バイアン・エイチ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schneider USA Inc
Original Assignee
Schneider USA Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Publication of JPH09506026A publication Critical patent/JPH09506026A/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/049—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/18—Materials at least partially X-ray or laser opaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0098—Catheters; Hollow probes having a strain relief at the proximal end, e.g. sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/0069—Tip not integral with tube

Abstract

A diagnostic catheter comprises an inner layer of 100 percent polyamide over which is a braided metal wire sleeve and an outer layer formed as a blend of either the polyamide and PEBA along with a suitable radiopaque filler or, alternatively, a blend of PEBA having different durometers. Affixed either directly to the end of the above tubular body or to a stem member secured to that tubular body is a soft-tip formed from a blend of PEBA whose hardness is such that the catheter can be considered as having an atraumatic tip. The resulting catheter exhibits excellent torque and column strength characteristics while providing a relatively large diameter lumen for a given outside diameter.

Description

【発明の詳細な説明】 発明の背景 本件発明は脈管内用カテーテルに関し、より詳細には
比較的大きい直径の内部ルーメンのための比較的小さい
外径を有しかつ優れた押し込み特性及びトルク特性を有
している診断用カテーテルに関する。Description: BACKGROUND OF THE INVENTION The present invention relates to intravascular catheters, and more particularly to a catheter having a relatively small outer diameter for a relatively large diameter inner lumen and excellent push and torque characteristics. The present invention relates to a diagnostic catheter having the same.

患者の冠状動脈疾患の状況を観察する際に、所定の血
管の開存性を見るために血管造影法が使用される。この
方法を行う場合に、所望の末端部曲げ形状を有する診断
用カテーテルがセルデンジャ（Seldinger）法を使用し
て大腿動脈内に導入され、該カテーテルの末端部が診断
される特定の冠状動脈内へ操縦されるまで患者の血管組
織を介してガイドワイヤ上を前進される。小さい患者に
は上腕アプローチが使用される。When observing the state of a patient's coronary artery disease, angiography is used to determine the patency of certain blood vessels. In performing this method, a diagnostic catheter having a desired distal bent shape is introduced into the femoral artery using the Seldinger technique, and the distal end of the catheter is inserted into the particular coronary artery to be diagnosed. It is advanced over the guidewire through the patient's vascular tissue until maneuvered. The brachial approach is used for small patients.

診断用カテーテルによって取られる通路が非常に蛇行
している場合には、該カテーテルがその基端ハブを回転
することにより操縦されることが出来かつその回転が円
滑な制御可能な状態で末端部まで伝達されることが優れ
た診断用カテーテルであるための基本である。更にこの
カテーテルはこれが血管組織を介して前進されるときに
捩れたり折れ曲がることがないように長手方向において
十分な強度を持たねばならない。更にまたガイドワイヤ
の通過を容易にし、又はそこを通るかもしれない他のカ
テーテルの通過を容易にするため潤滑性のコアルーメン
を持たねばならない。If the passage taken by the diagnostic catheter is very tortuous, the catheter can be steered by rotating its proximal hub and its rotation can be smoothly controlled to the distal end. Transmission is the basis for an excellent diagnostic catheter. Further, the catheter must have sufficient strength in the longitudinal direction so that it does not twist or bend as it is advanced through vascular tissue. Furthermore, it must have a lubricating core lumen to facilitate passage of the guidewire, or of other catheters that may pass therethrough.

また検査しようとする血管組織の部分がＸ線透視装置
によって透視可能なように、Ｘ線不透過性コントラスト
液のような液体がそこを介して射出されかつ末端部から
出ることが出来るように比較的大きいルーメンを有する
ことが診断用カテーテルの好ましい特徴である。Also, a liquid, such as a radiopaque contrast liquid, can be ejected therethrough and exit from the distal end so that the portion of the vascular tissue to be examined can be seen through a fluoroscope. Having a large lumen is a preferred feature of a diagnostic catheter.

比較的小さい外径と比較的大きい内径とを有するカテ
ーテルの好ましい特徴はかなり薄い壁を持つことを要求
する。薄い壁を持つカテーテルの所望のトルク特性及び
押し込み特性を維持することは、使用される材料の公式
及び利用される構造的技術においてかなりの発明力を要
求するものである。Preferred features of a catheter having a relatively small outer diameter and a relatively large inner diameter require having a relatively thin wall. Maintaining the desired torque and push characteristics of a thin walled catheter requires considerable inventive power in the formulation of the materials used and the structural techniques employed.

ギャング等（Jang et al）の米国特許第4898591号
は、内部管状層及び外部管状層から形成された管状本体
を有する診断用カテーテルについて開示しており、ここ
では内部層と外部層との間に強化編み部が配置されてい
る。各内部層と外部層とは、ナイロンとエステル結合さ
れたポリエーテル・ポリアミドのコポリマとのブレンド
から形成されている。U.S. Pat. No. 4,985,91 to Jang et al discloses a diagnostic catheter having a tubular body formed from an inner tubular layer and an outer tubular layer, wherein a catheter is disposed between the inner and outer layers. A reinforcing knit is arranged. Each inner and outer layer is formed from a blend of a polyether polyamide copolymer esterified with nylon.

本件発明は、上記ギャング等の特許によって代表され
るような公知の技術の改良であり、最小の外径と最大の
内径とを有し同時に必要なトルク特性と押し込み特性と
を維持しているような診断用カテーテルを提供するもの
である。ここに開示される種々の層のための方法及び要
素を使用することによって、例えば外径が4Frである
が、現在市販されているような5Frカテーテルの内部ル
ーメンと同様の大きさの内部ルーメンを有するような診
断用カテーテルを設計することが可能となった。同様に
本件発明によって形成される6Frカテーテルは、市販さ
れている7Frカテーテルの内部ルーメンとほぼ同様の内
部ルーメンを有するのである。The present invention is an improvement of a known technique typified by the above-mentioned gang et al. Patent, which has a minimum outer diameter and a maximum inner diameter, and at the same time maintains necessary torque characteristics and pushing characteristics. The present invention provides a novel diagnostic catheter. By using the methods and elements for the various layers disclosed herein, an inner lumen, e.g., having an outer diameter of 4 Fr but similar in size to the inner lumen of a 5 Fr catheter as currently commercially available, can be obtained. It has become possible to design a diagnostic catheter having the above. Similarly, the 6Fr catheter formed according to the present invention has an inner lumen that is substantially similar to the inner lumen of a commercially available 7Fr catheter.

発明の概要 本件発明によれば、基端部と、末端部と、両者間に伸
びているルーメンであってその管状の本体が好ましくは
ナイロン−12のような基本的に非変性（unmodified）ポ
リアミドポリマからなっている内部層で形成されている
ルーメンと、を有する細長い管状の本体を備えた診断用
の脈管用カテーテルを提供される。ここに使用されてい
る“非変性（unmodified）ポリアミドポリマ”の用語
は、実質的にポリマの物理的特性を変更するであろうポ
リアミド基ポリママトリックス（polyamide-based poly
mer matrices）又はポリマ性能強化物（polymer perfor
mance enhancers）に関するコポリマ、ポリマブレン
ド、混和可能（miscible）ポリマ等のような、実質的に
物理的特性を変更する傾向を有するポリママトリックス
へ何も付加されていないことを言うものである。例えば
着色剤又はＸ線不透過性充填物質が付加されることは変
性であるとは考えられないのである。ナイロン−12は疎
水性の意味であり湿気や膨張を吸収しない。この内部層
を取り囲んでいるものが補強スリーブであり、このスリ
ーブは管状の本体の基端部から末端部の方へ伸びてい
る。スリーブは編んだフィラメントでありかつ内部層を
圧縮しており、これによりこの内部層はルーメンを画定
している壁面に顕微鏡的なこぶを形成し、これが差し込
まれたガイドワイヤと壁面との間の接触面積を有効に減
少している。SUMMARY OF THE INVENTION In accordance with the present invention, a proximal and distal end, a lumen extending therebetween, the tubular body of which is preferably an essentially unmodified polyamide such as nylon-12. A vascular catheter for diagnosis comprising an elongated tubular body having a lumen formed of an inner layer of a polymer. The term “unmodified polyamide polymer” as used herein refers to a polyamide-based polymer matrix that will substantially alter the physical properties of the polymer.
mer matrices or polymer perfor
Nothing is added to polymer matrices that have a substantial tendency to change physical properties, such as copolymers, polymer blends, miscible polymers, etc. with respect to mance enhancers. For example, the addition of colorants or radiopaque fillers is not considered to be a modification. Nylon-12 is hydrophobic and does not absorb moisture or swelling. Surrounding this inner layer is a stiffening sleeve, which extends from the proximal end to the distal end of the tubular body. The sleeve is a knitted filament and compresses the inner layer, which forms a microscopic hump on the wall defining the lumen, which is inserted between the inserted guidewire and the wall. The contact area is effectively reduced.

ショアＤ硬度で約50〜75の範囲の所定の直径硬度を有
しかつ好ましくはＸ線不透過性充填材料（BaSO4）を有
しているポリエーテルブロックアミドのブレンドを含ん
でいる外部層が内部層と補強スリーブとを覆い、かつ管
状の本体に対して３〜8Frの範囲の外部層を提供してい
る。Outer layer and having a predetermined diameter hardness in the range of about 50 to 75 in Shore D hardness preferably includes a blend of polyether block amide having a X-ray opaque filler material (BaSO 4) is It covers the inner layer and the reinforcing sleeve and provides an outer layer in the range of 3-8 Fr for the tubular body.

好ましくはソフトチップ部材が管状の本体部材の末端
部に取り付けてある。このソフトチップ部材はショアＤ
硬度で約45以下の硬度を示すような樹脂のブレンドから
成形されている。Preferably, a soft tip member is attached to the distal end of the tubular body member. This soft tip member is Shore D
It is molded from a resin blend having a hardness of about 45 or less.

またこの脈管内カテーテルは、管状の本体とソフトチ
ップ部材との間に配置されかつその両者に接合されてい
る編んでいない管状ステム部材を有している。このステ
ム部材自体は好ましくは、ポリアミドとショアＤ硬度が
25〜72の範囲の硬度を有しているPEBAとのコポリマの単
一層を有している。これは均一又はテーパ付きの外径を
有することもできる。The intravascular catheter also has an unbraided tubular stem member disposed between and joined to the tubular body and the soft tip member. The stem member itself preferably has a polyamide and Shore D hardness.
It has a single layer of a copolymer with PEBA having a hardness in the range of 25-72. It can also have a uniform or tapered outer diameter.

ソフトチップまたはステム部材を、編んだ補強用の管
状本体へ熱的に接合使用とするとき、該編み部材を形成
している針金の切断した自由端は、熱によって歪み、ル
ーメン内へ又は外壁を介して、管状の本体の熱で軟化し
た壁を介して入り込むであろう。この問題を未然に防止
するために、本件発明のカテーテルは一般に適当な金属
又はカプトン（KAPTON）の商標名で販売されているポリ
イミドのような耐高温性のプラスチックで形成されたリ
ング又はバンドを有している。この薄いリングは該編み
部材を形成している針金の端部を補縛し、それらの端部
がほつれたり、又はソフトチップ又は管状ステム部材の
熱接合が行われたときに歪むのを防止している。When the soft tip or stem member is to be used for thermal bonding to a knitted reinforcing tubular body, the cut free end of the wire forming the knitted member may be distorted by heat and cause the outer wall to enter the lumen or the outer wall. Through the heat-softened wall of the tubular body. To obviate this problem, the catheters of the present invention generally have a ring or band formed of a suitable metal or high temperature resistant plastic such as polyimide sold under the KAPTON brand name. doing. The thin ring stakes the ends of the wire forming the braid and prevents them from fraying or warping when thermal bonding of the soft tip or tubular stem member is performed. ing.

図面の説明 本件発明の上記特徴、目的、及び利点等は、好ましい
実施例に付いての下記の詳細な記載から、特にいくつか
の図面において同様の部材に同様の番号を付している添
付図面を参照したとき、当業者によって明白となろう。BRIEF DESCRIPTION OF THE DRAWINGS The above features, objects, advantages, and the like of the present invention can be obtained from the following detailed description of the preferred embodiments, particularly when referring to the accompanying drawings, in which like reference numerals designate like parts throughout the several views. Will be apparent to those skilled in the art when referred to.

図１は本件発明によって構成された診断用カテーテル
の斜視図である。FIG. 1 is a perspective view of a diagnostic catheter constructed according to the present invention.

図２は図１に示すカテーテルの線２−２に沿って見た
断面図である。FIG. 2 is a cross-sectional view of the catheter shown in FIG. 1 taken along line 2-2.

図３は図１の線３−３に沿って取ったカテーテルのス
テム部材を見た断面図である。FIG. 3 is a cross-sectional view of the catheter stem member taken along line 3-3 of FIG.

図４は管状本体ストックとステム部材との間の接合部
を通る線４−４に沿って見た長手方向断面図である。FIG. 4 is a longitudinal cross-sectional view taken along line 4-4 through the junction between the tubular body stock and the stem member.

図５は図１の線５−５に沿って見たテーテルの末端部
の長手方向断面図である。FIG. 5 is a longitudinal cross-sectional view of the distal end of the catheter, taken along line 5-5 in FIG.

好ましい実施例に関する記載 初めに図１を参照すると、ここには本件発明を形成し
ている診断用カテーテルが符号10にて概括的に示されて
いる。このカテーテル10は、基端部14と、末端部16と、
これらの間に伸びているルーメン18と、を含んでいる細
長い管状の本体12を有している。管状本体12の基端部14
には成形されたプラスチック製ハブ20が取り付けられて
いる。このプラスチック製ハブ20は、その基端部にルア
（Luer）取付具22と、カテーテルの捩りを容易にするた
め直径方向に対向した側面から半径方向に突出している
張り広がったウイング24と、を有している。エラストマ
ー製のスリーブ26が管状本体12の基端部を取り囲んでお
り、これが歪み解放部材として機能している。このスリ
ーブ26は好ましくは粗く又はこぶ付き状態に形成されて
おり３本指カテーテル係合部（three-finger catheter
engagement）を使用して該スリーブの把持及び回転を容
易にしている。この管状本体12の長さは標準的には3.5
〜４フィートで全長にわたってほぼ均一な外径を有して
おり、例えば3Frから8Frまでの種々の寸法となってい
る。DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring first to FIG. 1, a diagnostic catheter forming the present invention is indicated generally at 10. This catheter 10 has a proximal end 14, a distal end 16,
An elongated tubular body 12 including a lumen 18 extending therebetween. Proximal end 14 of tubular body 12
Is mounted with a molded plastic hub 20. The plastic hub 20 has a Luer fitting 22 at its proximal end and an expanded wing 24 which projects radially from diametrically opposed sides to facilitate twisting of the catheter. Have. An elastomeric sleeve 26 surrounds the proximal end of the tubular body 12, which functions as a strain relief. The sleeve 26 is preferably formed in a rough or humped state and includes a three-finger catheter.
engagement) to facilitate gripping and rotation of the sleeve. The length of this tubular body 12 is typically 3.5
It has a substantially uniform outer diameter over its entire length of ４4 feet and has various dimensions, for example, from 3 Fr to 8 Fr.

図２に示す断面図を参照すると、この管状本体12が好
ましくはナイロン−12（商標名）のような非変性（unmo
dified）ポリアミドである内部層28から形成されている
ことが分かる。この内部層28のための物質としてのポリ
アミドにより、ルーメン18を画定している表面は本来的
に滑らかである。更にナイロン−12は湿気を吸収しない
ことが分かっており、このため塩類、体液及び／又は比
較媒体液に浸けたときにも寸法変化をもたらさないであ
ろう。この内部層12は好ましくは0.00254〜0.02032cm
（0.001〜0.008インチ）好ましくは0.00635±0.0127cm
（0.0025±0.0005インチ）の壁厚を有している。Referring to the cross-sectional view shown in FIG. 2, the tubular body 12 is preferably an unmodified, such as nylon-12.
dified) from the inner layer 28 which is a polyamide. Due to the polyamide as the material for this inner layer 28, the surface defining the lumen 18 is inherently smooth. In addition, nylon-12 has been found to not absorb moisture, and will not result in dimensional changes when immersed in salts, body fluids and / or comparative media fluids. This inner layer 12 is preferably 0.00254-0.02032 cm
(0.001-0.008 inch) preferably 0.00635 ± 0.0127cm
(0.0025 ± 0.0005 inch) wall thickness.

図２及び図４に示す断面図から分かるように、該内部
層28の回りには金属製針金30からなる編みスリーブが形
成されている。より詳細には、内部層28は標準的にはポ
リアセタール製のマンドレル上に押し出され、次いで、
ステンレス鋼製の編み針金を使用して編まれる。多くの
編みパターンのうちのいずれか一つのパターンが、例え
ば上部に２本−下部に２本、又は上部に１本−下部に１
本づつを編むことにより形成されている。この編み角度
はカテーテルの垂直面から20°〜60°の範囲に調整され
よう。また限定事項ではないが、この編み針金の直径は
0.00254〜0.0762cm（0.0010〜0.0030インチ）の範囲で
あろう。これらの針金が中央の内部層28の周りに編まれ
るときに、編み針金とナイロン−12内部層との間の接触
点に僅かな変形を発生し、これがルーメン18の表面に小
さな凹凸を発生する。これらの凹凸は、ルーメンを介し
て差し込まれるガイドワイヤまたは血管形成カテーテル
との間の有効な壁接触面積を減少し、それによりナイロ
ン−12材料自体の潤滑特性によって提供されるよりも更
に一層多く摩擦を減少することが分かっている。As can be seen from the cross-sectional views shown in FIGS. 2 and 4, a knit sleeve made of a metal wire 30 is formed around the inner layer 28. More specifically, the inner layer 28 is extruded onto a mandrel, typically made of polyacetal, and then
Knitted using stainless steel knitting wire. Any one of a number of knitting patterns, for example, two at the top-two at the bottom, or one at the top-one at the bottom
It is formed by knitting each book. This knitting angle will be adjusted in the range of 20 ° to 60 ° from the vertical plane of the catheter. Also, although not a limitation, the diameter of this knitting wire is
It will range from 0.00254 to 0.0762 cm (0.0010 to 0.0030 inches). As these wires are knitted around the central inner layer 28, a slight deformation occurs at the point of contact between the knitting wire and the nylon-12 inner layer, which causes small irregularities on the surface of the lumen 18. I do. These irregularities reduce the effective wall contact area between the guidewire or angioplasty catheter inserted through the lumen, thereby providing even more friction than provided by the lubricating properties of the nylon-12 material itself. Has been found to decrease.

編み行程の後に、外部層32がこの組立体上に押し出さ
れる。この外部層は、約50ショアＤ〜75ショアＤの範囲
の所定のデウロメータ硬度を持つポリエーテルブロック
アミド（PEBA）から構成され、好ましくは硫酸バリウム
BaSO4のようなＸ線不透過性充填剤を有している。図２
及び図４に示す断面図から明らかなように、外部層32は
全体的に編みスリーブに埋め込んであり、押し出し機に
て使用されるダイスが3Fr〜8Frの範囲のいずれかの寸法
に選択される管状本体に外径をもたらしている所定の壁
厚を提供するであろう。After the knitting process, the outer layer 32 is extruded onto this assembly. The outer layer is comprised of polyether block amide (PEBA) having a predetermined deurometer hardness in the range of about 50 Shore D to 75 Shore D, preferably barium sulfate.
And a X-ray opaque fillers, such as BaSO 4. FIG.
4 and the cross-sectional view shown in FIG. 4, the outer layer 32 is entirely embedded in the knitted sleeve, and the dies used in the extruder are selected to have any size in the range of 3Fr to 8Fr. It will provide a predetermined wall thickness providing an outer diameter for the tubular body.

カテーテルの内部層28は、好ましくは、100％ナイロ
ン−12ポリアミドから形成されているが、外部層はポリ
エーテルブロックアミドのブレンドにより形成されてい
る。このブレンドは所望の剛性特性又は“感触”を有す
るカテーテル本体をもたらすよう異なった硬度を示して
いる。外部層32はまたポリアミドとPEBAとのブレンドと
することもできるであろう。例えば、外部層は、Ｘ線不
透過性充填剤として付加された36％硫酸バリウムを含む
72D硬度のPEBAを63.8重量％と、管状本体に対して所望
の色彩を提供するため顔料を0.2重量％と、を含むブレ
ンドとすることもできるであろう。別の例ではこの外部
層は、ポリアミドを19.3重量％と、70D硬度のPEBAを44.
5％と、硫酸バリウムを36重量％と、更に色彩を付加す
るための顔料を0.2重量％と、を含むブレンドから形成
することもできるであろう。The inner layer 28 of the catheter is preferably formed from 100% nylon-12 polyamide, while the outer layer is formed from a blend of polyether block amides. The blend exhibits different hardnesses to provide a catheter body having the desired stiffness properties or "feel". The outer layer 32 could also be a blend of polyamide and PEBA. For example, the outer layer comprises 36% barium sulfate added as a radiopaque filler
A blend could include 63.8% by weight PEBA with 72D hardness and 0.2% by weight pigment to provide the desired color to the tubular body. In another example, the outer layer comprises 19.3% by weight of polyamide and 44.
It could also be formed from a blend containing 5%, 36% by weight of barium sulfate and 0.2% by weight of a pigment for adding color.

診断用カテーテルの末端部に対する所望の形状特性を
提供するために、管状ステム部材34は編んだ管状本体12
の末端部へ熱的に接合されている。図４によく示すよう
に、この編んだ管状本体は符号36にて示すように傾斜部
に削り取られた外部層32を有している。管状本体12の末
端部16を傾斜状態にすることにより、より多くの面積が
ステム部材34の取り付けをもたらすために提供される。
このような傾斜部を形成するために使用された削り取り
作業は編みスリーブを形成している針金30の端部に対す
る外方ジャケットの厚みを減少しているので、編み針金
の自由端を取り囲んでいる非貫通材料のバンド又はリン
グ38を提供することが便利であることが分かっている。
そのようなバンドなしで、管状本体12とジャケット34と
の間に熱接合をもたらすのに要求される加熱は、編み部
のすり切れた端部を、それらがルーメン18内に内部層28
を介して又は管状ステム34の厚みを介して浸透すること
が出来る点までゆがめ又は曲げることが出来る。このバ
ンド38はこれらの端部を加熱の間中制限しており、その
ような望ましくない壁の浸透を防いでいる。意図された
制限はないので、非浸透性の材料からなるこのバンド
は、タンタル、チタニウム、イリジウム、金、銀、ステ
ンレル綱、及びそれらの材料の合金等から構成される金
属を含むことが出来る。また、編み針金の自由端が熱接
合リフロー処置の間にカテーテルの内部又は外部壁に侵
入しないように制限するため、カプトン（登録商標KAPT
ON）のようなポリイミドなどの適当な高温ポリマ類が、
使用されうる。In order to provide the desired shape characteristics to the distal end of the diagnostic catheter, the tubular stem member 34 is
Is thermally joined to the end of the. As best shown in FIG. 4, the braided tubular body has an outer layer 32 that is cut off at the ramp as shown at 36. By tilting the distal end 16 of the tubular body 12, more area is provided to provide for attachment of the stem member.
The scraping operation used to form such a ramp reduces the thickness of the outer jacket relative to the end of the wire 30 forming the knitting sleeve and thus surrounds the free end of the knitting wire. It has proven convenient to provide a band or ring of non-penetrating material.
Without such a band, the heating required to provide a thermal bond between the tubular body 12 and the jacket 34 would reduce the worn ends of the braid, and the inner layer 28 into the lumen 18.
Can be distorted or bent to the point where it can penetrate through or through the thickness of tubular stem 34. This band 38 limits these ends during heating, preventing such unwanted wall penetration. As there is no intended limitation, this band of non-permeable material can include metals composed of tantalum, titanium, iridium, gold, silver, stainless steel, alloys of those materials, and the like. In order to limit the free end of the knitting wire from entering the inner or outer wall of the catheter during the thermal bonding reflow procedure, Kapton (registered trademark KAPT®)
ON) suitable high temperature polymers such as polyimide,
Can be used.

ステム部材34は、ナイロン−12のようなポリアミド
と、25D〜72Dの範囲のPEBAと、所望の顔料が付加された
硫酸バリウムなどのＸ線不透過性の充填剤と、のブレン
ドから成っている。Stem member 34 comprises a blend of a polyamide such as nylon-12, PEBA in the range of 25D-72D, and a radiopaque filler such as barium sulfate with the desired pigment added. .

このカテーテルにはソフト・チップ部材40が設けてあ
り、この部材40はステム部材34の末端部に接合されてい
る。このカテーテルへのソフト・チップの形成に際し
て、適当な低デユロメータ（25D〜40D）のようなPEBAが
使用され得る。また、BaSO4のようなＸ線不透過性の充
填剤を重量で15％〜45％のPEBAブレンドが使用される。
特に48.6％ 25D PEBA、32.4％ 40D PEBA,15％ BaSO4、
及び４％ TiO2顔料からなる樹脂ブレンドがソフトなア
トロウマチック（atraumatic）チップを提供することが
分かっている。このチップは、ステム部材34の末端部の
材料を射出成型することにより形成されよう。又はもし
カテーテルがステム部材を含むように設計されていない
なら、このソフトチップ部材40は、該ソフトチップが形
成されるときに前記編んだ針金端部を制限するために使
用されている非貫通材料のリング38と共に、該編んだ管
状本体12の末端部に直接射出成型されるであろう。The catheter is provided with a soft tip member 40, which is joined to the distal end of the stem member. In forming a soft tip into the catheter, a PEBA, such as a suitable low durometer (25D-40D) may be used. Further, PEBA blend of 15% to 45% of the X-ray opaque filler by weight, such as BaSO 4 is used.
Especially 48.6% 25D PEBA, 32.4% 40D PEBA, 15% BaSO 4 ,
It has been found that a resin blend consisting of and 4% TiO 2 pigment provides a soft atraumatic chip. This tip may be formed by injection molding the material at the distal end of stem member 34. Or, if the catheter is not designed to include a stem member, the soft tip member 40 may be a non-penetrating material used to limit the braided wire end when the soft tip is formed. Would be injection molded directly to the distal end of the braided tubular body 12 with the ring 38 of FIG.

上記技術を使用することにより、直径0.06604cm（0.0
26インチ）のルーメン即ち管腔を有しかつ優れたトルク
特性を同様に備えそれによりカテーテルの末端部がその
基端部の回転に従動するような、3Fr外径のカテーテル
を生産することが可能である。更に、外径に比較してか
なり大きな直径のルーメンであっても、このカテーテル
はよじれ又は曲げを生じることなく血管組織を介して該
カテーテルを押し込めることができる適切な柱状強度を
有している。本件発明によって構成される8Frの診断用
カテーテルは、0.19304cm（0.076インチ）程度のルーメ
ンを有しており、更にカテーテルの基端部に長手方向及
び回転方向の力を付与することにより操縦されうる限り
において、多くの心臓学者によって期待されるような所
望の特性を有しているであろう。By using the above technology, a diameter of 0.06604 cm (0.0
It is possible to produce catheters with an outer diameter of 3Fr which have a lumen of 26 inches and also have excellent torque characteristics, so that the distal end of the catheter follows the rotation of its proximal end It is. Furthermore, even with lumens that are significantly larger in diameter than their outer diameter, the catheter has adequate columnar strength to allow the catheter to be pushed through vascular tissue without kinking or bending. The 8Fr diagnostic catheter constructed in accordance with the present invention has a lumen on the order of 0.076 inches and can be steered by applying longitudinal and rotational forces to the proximal end of the catheter. Insofar, it will have the desired properties as expected by many cardiologists.

本件発明による脈管内カテーテルは異なる心臓学者の
要求を満足させる種々の異なった末端部形状を有するよ
うに製造されることが出来ることは当業者は、理解して
いるであろう。Those skilled in the art will appreciate that an intravascular catheter according to the present invention can be manufactured to have a variety of different end configurations that meet the needs of different cardiologists.

本件発明の精神及び範囲から出ることなく上記の実施
例及び例示に対して細部において種々の変形又は変更が
なされ得るであろう。よって添付の図面に関して述べら
れかつ示されたような記載の全ては単に例示であり限定
的なものでないことが理解されるであろう。Various changes or modifications may be made in the details to the above embodiments and illustrations without departing from the spirit and scope of the invention. Thus, it will be understood that all of the description as set forth and shown in connection with the accompanying drawings is illustrative only and not limiting.

フロントページの続き (56)参考文献 特開 平７−8563（ＪＰ，Ａ) 特開 平３−205062（ＪＰ，Ａ) 特開 昭61−87129（ＪＰ，Ａ) 特開 平６−327758（ＪＰ，Ａ) 特表 平４−502412（ＪＰ，Ａ) 米国特許4950257（ＵＳ，Ａ) 米国特許5318032（ＵＳ，Ａ) 欧州公開566755（ＥＰ，Ａ１) (58)調査した分野(Int.Cl.6，ＤＢ名) A61M 25/00 A61L 29/00 Continuation of the front page (56) References JP-A-7-8563 (JP, A) JP-A-3-205062 (JP, A) JP-A-61-87129 (JP, A) JP-A-6-327758 (JP) , a) JP-T flat 4-502412 (JP, a) United States Patent 4950257 (US, a) United States Patent 5318032 (US, a) European public 566755 (EP, A1) (58 ) investigated the field (Int.Cl. 6 A61M 25/00 A61L 29/00

Claims (18)

(57)【特許請求の範囲】(57) [Claims] 【請求項１】脈管内カテーテル（10）であって、 基端部（14）と、末端部（16）と、両者間に伸びている
ルーメン（18）と、を有する細長い管状の本体（12）を
備えており、 該管状の本体（12）が、 基本的に非変性ポリアミドポリマから成る内部層（28）
と、 対抗する自由端を有しているフィラメントからなる補強
スリーブ（30）であって、前記内部層（28）を取り囲み
かつ管状の本体（12）の基端部（14）から該管状の本体
（12）の末端部（16）の方へ所定の距離だけ伸びている
スリーブ（30）と、 ショアＤ硬度で50〜75の範囲の所定のデユロメータ硬度
のポリエーテルブロックアミド（PEBA）を含んでいる外
部層（32）であって、少なくとも部分的に前記補強スリ
ーブ（30）を覆っており、かつ前記管状の本体（12）に
３フレンチ〜８フレンチの範囲の外径を付与する壁厚を
有している外部層（32）と、 により形成されている脈管内カテーテル。An intravascular catheter (10) comprising an elongated tubular body (12) having a proximal end (14), a distal end (16), and a lumen (18) extending therebetween. Wherein said tubular body (12) comprises an inner layer (28) consisting essentially of an unmodified polyamide polymer.
A reinforcing sleeve (30) of filaments having opposing free ends, said sleeve surrounding the inner layer (28) and extending from the proximal end (14) of the tubular body (12). A sleeve (30) extending a predetermined distance toward the distal end (16) of (12); and a polyether block amide (PEBA) having a predetermined durometer hardness in the range of 50 to 75 in Shore D hardness. An outer layer (32) that at least partially covers the reinforcing sleeve (30) and has a wall thickness that gives the tubular body (12) an outer diameter in the range of 3 French to 8 French. An intravascular catheter formed by an outer layer (32) having the following. 【請求項２】更に、前記管状の本体（12）の末端部に接
合された管状のソフトチップ部材（40）を含み、このソ
フトチップ部材（40）が樹脂のブレンドから形成されて
おり、それにより該ソフトチップ（40）がショアＤ硬度
で45の硬度よりも少ない硬度を示していることを特徴と
する請求項１に記載の脈管内カテーナル。2. A tubular soft tip member (40) joined to a distal end of said tubular body (12), said soft tip member (40) being formed from a blend of resins. The intravascular catheter according to claim 1, wherein the soft tip (40) has a Shore D hardness of less than 45 in hardness. 【請求項３】更に、前記管状の本体（12）と前記ソフト
チップ部材（40）との間に配置されかつそれらに接合さ
れている管状ステム部材（34）を含み、該ステム部材
（34）がポリアミドとポリエーテルブロックアミドとの
コポリマであってショア硬度が25Dから72Dの範囲にある
コポリマから形成されていることを特徴とする請求項２
に記載の脈管内カテーテル。3. A tubular stem member (34) disposed between and joined to said tubular body (12) and said soft tip member (40), said stem member (34). Is a copolymer of polyamide and polyether block amide and is formed from a copolymer having a Shore hardness in the range of 25D to 72D.
An intravascular catheter according to claim 1. 【請求項４】前記内部層（28）が0.00254〜0.02032cm
（0.001〜0.008インチ）の範囲の壁厚を有する100％ポ
リアミドポリマから形成されている請求項１に記載の脈
管内カテーテル。4. The inner layer (28) has a thickness of 0.00254 to 0.02032 cm.
The intravascular catheter of claim 1, wherein the intravascular catheter is formed from 100% polyamide polymer having a wall thickness in the range (0.001 to 0.008 inches). 【請求項５】前記壁厚が好ましくは0.00635cm（0.0025
インチ）である請求項４に記載の脈管内カテーテル。5. The wall thickness is preferably 0.00635 cm (0.0025 cm).
5. The intravascular catheter of claim 4, wherein the catheter is in inches. 【請求項６】前記補強スリーブ（30）が前記内部層（2
8）と外部層（32）との間に全体的に埋められている請
求項１に記載の脈管内カテーテル。6. The reinforcing sleeve (30) is provided on the inner layer (2).
2. An intravascular catheter according to claim 1, wherein the intravascular catheter is entirely buried between the outer layer and the outer layer. 【請求項７】前記外部層（32）が更にＸ線不透過性の充
填材を有している請求項１に記載の脈管内カテーテル。7. The intravascular catheter according to claim 1, wherein the outer layer further comprises a radiopaque filler. 【請求項８】前記ステム部材（34）がＸ線不透過性の充
填材を有している請求項３に記載の脈管内カテーテル。8. The intravascular catheter according to claim 3, wherein said stem member (34) comprises a radiopaque filler. 【請求項９】前記管状の本体（12）と前記管状のステム
部材（34）とが同一の外径を有している請求項３に記載
の脈管内カテーテル。9. An intravascular catheter according to claim 3, wherein said tubular body (12) and said tubular stem member (34) have the same outer diameter. 【請求項１０】前記管状のステム部材（34）が前記管状
の本体（12）と前記管状のステム部材（34）との間の接
続部に前記管状の本体（12）の外径に等しい第１の外径
からより少ない直径までテーパが付けられている請求項
３に記載の脈管内カテーテル。10. The tubular stem member (34) is connected to the connection between the tubular body (12) and the tubular stem member (34) by a first diameter equal to the outer diameter of the tubular body (12). 4. The intravascular catheter of claim 3, wherein the catheter is tapered from an outer diameter of one to a smaller diameter. 【請求項１１】前記外部層（32）がナイロン−12ポリア
ミドと前記ポリエーテルブロックアミドとのブレンドで
あり、更にＸ線不透過性の充填材を有している請求項１
に記載の脈管内カテーテル。11. The outer layer (32) is a blend of nylon-12 polyamide and the polyether block amide and further comprises a radiopaque filler.
An intravascular catheter according to claim 1. 【請求項１２】前記ルーメン（18）が0.06604〜0.2032c
m（0.026〜0.080インチ）の範囲の直径を有しており、
前記外部層が0.09096〜0.2794cm（0.039〜0.110イン
チ）の範囲の外径を有している請求項１に記載の脈管内
カテーテル。12. The said lumen (18) is 0.06604 to 0.2032c.
m (0.026-0.080 inch) in diameter,
2. The intravascular catheter of claim 1, wherein the outer layer has an outer diameter in the range of 0.039-0.2794 cm (0.039-0.110 inches). 【請求項１３】前記ルーメン（18）が0.06604〜0.2032c
m（0.026〜0.080インチ）の範囲の直径を有しており、
前記外部層（32）が0.09906〜0.2794cm（0.039〜0.110
インチ）の範囲の外径を有している請求項11に記載の脈
管内カテーテル。13. The lumen (18) may be 0.06604 to 0.2032c.
m (0.026-0.080 inch) in diameter,
The outer layer (32) is 0.09906 to 0.2794 cm (0.039 to 0.110
12. The intravascular catheter of claim 11, having an outer diameter in the range of inches. 【請求項１４】前記ブレンドが、ポリアミドを19.3重量
％、PEBAを44.5重量％、BaSO4Ｘ線不透過性の充填材を3
6重量％、顔料を0.2重量％からなっている請求項11に記
載の脈管内カテーテル。14. The blend comprises 19.3% by weight of polyamide, 44.5% by weight of PEBA and 3% of BaSO 4 radiopaque filler.
12. The intravascular catheter according to claim 11, comprising 6% by weight and 0.2% by weight of pigment. 【請求項１５】前記外部層（32）が、72DのPEBAを63.8
重量％、BaSO4Ｘ線不透過性の充填材を36重量％、顔料
を0.2重量％、含んでいるブレンドからなっている請求
項１に記載の脈管内カテーテル。15. The outer layer (32) comprises 72D PEBA 63.8.
Wt%, intravascular catheter according to BaSO 4 X-ray impermeable filler 36 wt%, the pigment 0.2% by weight, according to claim 1 which is a blend that comprise. 【請求項１６】前記外部層（32）が、70DのPEBAを63.8
重量％、BaSO4Ｘ線不透過性の充填材を36重量％、顔料
を0.2重量％、含んでいるブレンドからなっている請求
項１に記載の脈管内カテーテル。16. The outer layer (32) comprises 70D PEBA 63.8.
Wt%, intravascular catheter according to BaSO 4 X-ray impermeable filler 36 wt%, the pigment 0.2% by weight, according to claim 1 which is a blend that comprise. 【請求項１７】前記ソフトチップ部材（40）が、25DのP
EBAを48.6重量％、40DのPEBAを32.4重量％、BaSO4Ｘ線
不透過性の充填材を15重量％、TiO2色素を４重量％、含
んでいるブレンドからなっている請求項11に記載の脈管
内カテーテル。17. The soft tip member (40) has a P of 25D.
The EBA 48.6 wt%, a PEBA of 40D 32.4 wt%, BaSO 4 X-ray impermeable filler 15 wt%, the TiO 2 pigment 4% by weight, according to claim 11 which is a blend that comprise Intravascular catheter. 【請求項１８】前記補強スリーブ（30）が、前記フィラ
メントの編み形状からなっている請求項１に記載の脈管
内カテーテル。18. An intravascular catheter according to claim 1, wherein said reinforcing sleeve (30) is in the form of a knit of said filament.
JP7529480A 1994-05-18 1995-02-27 Thin wall catheter with enhanced torque characteristics Expired - Lifetime JP2950995B2 (en)

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US5599325A (en) 1997-02-04
CA2189135A1 (en) 1995-11-23
AU1670695A (en) 1995-12-05
EP0759788A1 (en) 1997-03-05
DE69534565D1 (en) 2005-12-08
EP0759788B1 (en) 2005-11-02
US5403292A (en) 1995-04-04
JPH09506026A (en) 1997-06-17
ATE308351T1 (en) 2005-11-15
WO1995031226A1 (en) 1995-11-23
CA2189135C (en) 2001-06-12
MX9605630A (en) 1998-05-31
DE69534565T2 (en) 2006-06-14
US5725513A (en) 1998-03-10
AU688858B2 (en) 1998-03-19

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